Official Title: “Comparison of Pain Relief and Inflammatory Status in Women With Surgically Confirmed Endometriosis Treated With Atorvastatin, Oral Contraceptive or Combined Oral Contraceptives and Atorvastatin: Open Randomized Controlled Trial”

The purpose of this study is to determine whether atorvastatin (alone or in combination with oral contraceptive) is effective in treatment of pelvic pain and inflammatory response in women with endometriosis.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: November 2010

Intervention(s) in this Clinical Trial

• Drug: oral contraceptive (Mercilon)
  • oral contraceptive (20ug EE, 150ug DSG) 1 tablet a day p.o. for 21 days with 7 day break for 6 months
• Drug: atorvastatin + oral contraceptive
  • atorvastatin 20mg po a day for 6 months + oral contraceptive (20ug EE, 150ug DSG) 1 tablet po a day for 21 days with 7 day break for 6 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 2
  • oral contraceptive + atorvastatin
• Active Comparator: 1
  • oral contraceptive

Primary Measures

• pain relief
  • Time Frame: 3,6,12 months
    Safety Issue?: No

Secondary Measures

• inflammatory status
  • Time Frame: 6 months
    Safety Issue?: No

Inclusion Criteria:

• informed written consent
• premenopausal women aged 18-45
• clinical signs and symptoms of endometriosis for minimum 3 months with endometriosis confirmed at laparoscopy or laparotomy within last 4 months - 5 years (preferably with histological confirmation)
• pain symptoms of moderate intensity (dysmenorrhoea + dyspareunia + nonmenstrual pelvic pain > 6 points on Biberoglu & Behrman scale [1981])
• no clinical signs of sexually transmitted disease

Exclusion Criteria:

• cancer of the ovary, adrenals, endometrium, uterine cervix, breasts
• pregnancy or lactation
• unexplained uterine/cervical bleeding
• hormonal therapy within last 3 months (for GnRH analogs 6 months)
• irregular menses (> 35 days) or secondary amenorrhoea (>3 months)
• other chronic disease affecting pelvic or abdominal cavity (including PID, ulcerating colitis , Crohn's disease, recurrent interstitial cystitis)
• sexually transmitted disease (gonorrhoea, Chlamydia)
• uncontrolled diabetes mellitus type I or II, VTE or other contraindications to medicine used in the study
• chronic therapy with CYP3A4 inhibitors (including ketoconazole, erythromycin and others)

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Poznan University of Medical Sciences

Overall Clinical Trial Officials and Contacts

Antoni J Duleba, MD Study Chair University of California, Davies, USA  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00675779

Study ID Number: 204-08

ClinicalTrials.gov Identifier: NCT00675779

Health Authority: Poland: Ministry of Health